Senior Medical Writer
Proposal Management/Writing
BDM
US - Home or office based

We are seeking a Medical Writer/Senior Medical Writer to join our team based here in the US. This position can be either office based from one of our locations on the East Coast or a remote position can also be considered.

At Cytel we believe the clinical development of safe and effective medicines is crucial for human welfare. Our mission is to improve success rates in this endeavor via the optimal design, effective implementation and accurate data management of clinical trials.

We believe that if you don’t get the trial design right, nothing else matters; and that every sponsor should evaluate the option of an adaptive approach. While Cytel may be best known for our pioneering work in adaptive approaches, our growing clinical research customers rely on Cytel strategic consulting, statistical programming and end-to-end data management expertise.

As the world's largest biometrics CRO, all the major pharmaceutical, biotech and medical device companies are our customers along with scores of specialty and emerging sponsor companies. We also count among our customers and research partners the leaders in academia, at medical institutions and international regulatory agencies.

 

The Medical Writer independently prepares documents necessary for all phases of clinical drug development by organizing, analyzing, and interpreting scientific and statistical data. Such documents include, but are not limited to, clinical study reports, study protocols, investigator’s brochures, clinical summaries, briefing books and responses to authorities, abstracts and manuscripts.

 

Responsibilities include:

•     Works with Project Manager to develop timelines and resource plans for the production of clinical study reports and filings to regulatory authorities.

•     Reviews statistical analysis plans, summary table shells, and case report forms as required.

•     Performs quality control (QC) review of clinical study reports, and clinical sections of regulatory submissions

 

Qualifications and Experience:  

Minimum Education: BS/BSc/BA in a science or industry-related discipline.

Work Requirements: Minimum of 5 years of medical writing experience in a contract research organization (CRO), pharmaceutical, or biotech setting.

Skills: Working knowledge of ICH and other regulatory guidelines. Broad knowledge of global pharmaceutical regulatory requirements, and experience in clinical research or other areas of the pharmaceutical industry. The ability to accurately and clearly present clinical data as well as strong verbal and interpersonal communication skills. Fluency in English (spoken and written) is required. Excellent writing (e.g., English usage) and a keen attention to detail also are required. Proficiency in Microsoft Word and graphic presentations is required. A degree of experience in using e-submission systems.

 
You have the option to work from home or be based either in our Chesterbrook, PA or Waltham, MA location.

 
Compensation & Benefits
We offer a competitive compensation package including base and bonus, as well as comprehensive medical and dental benefits and a contributing 401K plan.

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies. 



 

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